Skip to main content
OpenTrials
Completed

NCT Number: NCT02208674

Early Identification and Action in CKD

Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Albuminuria Cardiovascular Diseases Chronic Disease Disease Attributes Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months
  • scheduled laboratory appointment for serum creatinine testing within the next 30 days
  • average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months.

Exclusion criteria

  • fewer than 2 blood pressure readings in the prior 12 months,
  • pregnancy
  • current hospitalization
  • life expectancy less than 6 months as determined by the study investigators

Treatment and study plan

Protocolized, pharmacist-delivered CKD Action Plan

Other

The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD

Other names: Health care delivery procedure

Primary outcomes

  1. Screening Urinary Albumin Excretion

    Time frame: At 12 months

    Completed test for urine albumin/creatinine (or urine protein/creatinine)

Secondary outcomes

  1. Dyslipidemia Screening

    Time frame: At least once after eGFR < 60 ml/min

    One-time test for dyslipidemia (lipid panel)

  2. ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)

    Time frame: within 12 months of enrollment date

  3. Statin Treatment

    Time frame: Within 12 months of enrollment

    If age >= 50

  4. Blood Pressure Control-1

    Time frame: Average of last two readings prior to 12 months post-enrollment

  5. Blood Pressure--II

    Time frame: Average of all blood pressures within 12 month study period

  6. Blood Pressure--III

    Time frame: at 12 months post enrollment

    Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period

  7. Biochemical Surveillance

    Time frame: two weeks after initiation or titration of ACEI or ARB

    Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.

  8. Symptomatic Adverse Drug Event

    Time frame: At 12 months post-enrollment

    Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug

  9. Patient and Provider Satisfaction

    Time frame: 9-12 months post study start date

    Based on administered surveys

  10. Cystatin C Supplementary Screening

    Time frame: within 12 months of enrollment date

    One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.